scholarly journals Effectiveness and Impact of Capsaicin 8% Patch on Quality of Life in Patients with Lumbosacral Pain: An Open-label Study

2016 ◽  
Vol 7;19 (7;9) ◽  
pp. E1049-E1053 ◽  
Author(s):  
Panagiotis Zis
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Care Center ◽  
Controlled Study ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Vas Score ◽  
The Impact

Background: Capsaicin 8% patch (Qutenza™) is mainly used to treat postherpetic neuralgia and HIV-associated neuropathy. Evidence of the efficacy of Qutenza in other forms of neuropathic pain is lacking. Objective: To evaluate the analgesic effect and the impact on quality of life after a single application of the capsaicin 8% cutaneous patch in patients with lumbosacral pain. Study Design: Prospective open-label study of capsaicin 8% patch in patients with lumbosacral pain. Setting: Outpatient Pain and Palliative Care Center. Methods: All recruited patients were evaluated prior to capsaicin 8% patch administration and were followed-up at 2 weeks, at 8 weeks, and at 12 weeks post administration. Visual analog scale (VAS) was used to record pain intensity and EQ-5D was used to assess the quality of life of the participants. Results: Ninety patients met our inclusion criteria (54.4% men, mean age 59.1 ± 9.2 years). At baseline the mean VAS score of the participants was 7.6 ± 0.7. A statistically significant reduction of the VAS score between baseline and week 2 (mean VAS score 5.6 ± 1.1, P < 0.001) was observed. The therapeutic effect further continued between week 2 and week 8 (mean VAS score 3.2 ± 1.2, P < 0.001) and between week 8 and at endpoint at week 12 (mean VAS score 2.6 ± 1.1, P < 0.001). Between baseline and weeks 2, 8, and 12 (end-point) a significant improvement in all 5 dimensions of EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression) was observed (P < 0.001) Limitations: As it is an open-label study, a prospective randomized placebo-controlled study should be designed to confirm the effectiveness of capsaicin 8% patch in patients with lumbosacral pain. Conclusions: Administration of the capsaicin 8% patch resulted in a significant relief of neuropathic pain and a significant improvement of the quality of life of patients with lumbosacral neuropathic pain. Key words: Lumbosacral pain, peripheral pain, Qutenza, neuropathic pain, capsaicin, patch, quality of life, effectiveness

scholarly journals Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study

2020 ◽  
Author(s):  
Janet H. Ford ◽  
Virginia L. Stauffer ◽  
Peter McAllister ◽  
Sreelatha Akkala ◽  
Matthew Sexson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Phase ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Patient Reported ◽  
Domain Scores

Abstract Purpose Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine. Methods CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18–65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed. Results A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: −33.58 ± 2.11 (GMB 120 mg) and −32.67 ± 2.04 (GMB 240 mg). Conclusion Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

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